BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System— 510(k) K230956

Name: FDA 510(k) clearance K230956
Creator: U.S. Food and Drug Administration
Published: 2023-07-31

Substantially Equivalent

Bd Integrated Diagnostic Solutions /

FDA 510(k) clearance K230956 for BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System, Substantially Equivalent on 2023-07-31. Applicant: Bd Integrated Diagnostic Solutions /. Device class: 2.

Clearance details

Applicant: Bd Integrated Diagnostic Solutions /
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2023-04-04
Decision date: 2023-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QOF

view all

K252932 — Fast PCR Mini Respiratory Panel2026-06-12
K252269 — FINDER Flu A&B/SARS-CoV-2 Test2026-03-30
K251742 — VELO Respiratory Test2026-02-13
K251978 — LIAISON NES FLU A/B, RSV & COVID-192025-12-23
K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)2025-10-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.